FDA 510(k) & PMA Clearances Monitor — New Device Approvals

Track newly cleared FDA medical devices since your last run — 510(k) clearances and PMA approvals — from the official openFDA device APIs. Filter by keyword, applicant or product code. Clean JSON built for regulatory, competitive-intelligence and medtech sales workflows.

What does this Actor do?

It reads openFDA's two device decision endpoints — device/510k for premarket notifications and device/pma for premarket approvals — over a date window, merges them into one schema, and emits the result as a scheduled change feed.

The merge is the work, because 510(k) and PMA are not the same kind of record. A 510(k) has a K-number, a device_name and a prose decision description. A PMA has a P-number, a trade_name and a generic_name, a decision code rather than a description, and can carry a supplement number for a subsequent change to an approved device. Rather than force one onto the other, this Actor maps both onto a shared shape, marks which side each row came from in source, and leaves genuinely source-specific fields null. PMA supplements get a compound clearanceId like P980022/S045, so a supplement never collides with its parent approval.

Every row carries a direct link into the FDA's own CDRH database, and the untouched source record stays in raw.

Who is it for?

• Medtech competitive intelligence teams watching what rivals just got cleared to sell.
• Regulatory affairs professionals tracking decisions in their product codes and advisory panels.
• Medical device sales teams who want to reach a manufacturer at the moment a device clears.
• Investors and analysts monitoring a company's regulatory milestones as they become public.
• AI agent builders who want an FDA device tool with a stable output schema.

Use cases

• Watch a product code and get every new clearance in that device category.
• Monitor named competitors by applicants and see their approvals the week they land.
• Track a device keyword — infusion pump, continuous glucose, surgical robot — across both pathways at once.
• Feed new clearances into a competitive-intelligence digest with the FDA link attached.
• Give an agent a tool that answers "what devices were cleared in this category recently?"

What you get

One row per clearance or approval. Any value a source does not publish is null — the field is always present, and the untouched source record stays in raw.

Field	Type	Description
source	string	510k or pma
clearanceId	string	K-number for 510(k). For PMA, the P-number, with /supplement appended where the record is a supplement
deviceName	string	510(k) device name, or the PMA trade name
genericName	string	Generic device name. PMA only — always null on 510(k) rows
applicant	string	Company that filed for the clearance or approval
decisionDate	string	FDA decision date, as an ISO 8601 UTC midnight timestamp
decisionDescription	string	510(k): the decision description in prose. PMA: the decision code
clearanceType	string	510(k) clearance type, e.g. Traditional, Special. Literally PMA on PMA rows
productCode	string	FDA product code for the device category
advisoryCommittee	string	Advisory committee / medical specialty panel description
expedited	boolean	true where the FDA flagged expedited review, otherwise null
url	string	Direct link to the record in the FDA CDRH database
raw	object	The complete original openFDA record, unmodified
newSinceLastRun	boolean	Whether the decision date is newer than the saved watermark
retrievedAt	string	ISO 8601 timestamp of when this row was fetched

Sample output record

{
  "source": "510k",
  "clearanceId": "K261847",
  "deviceName": "Example Ambulatory Infusion Pump",
  "genericName": null,
  "applicant": "Example Medical Systems, Inc.",
  "decisionDate": "2026-08-07T00:00:00.000Z",
  "decisionDescription": "Substantially Equivalent",
  "clearanceType": "Traditional",
  "productCode": "LKK",
  "advisoryCommittee": "General Hospital",
  "expedited": null,
  "url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261847",
  "raw": { "k_number": "K261847", "…": "…" },
  "newSinceLastRun": true,
  "retrievedAt": "2026-08-23T10:31:44.208Z"
}

How to use it

Watch a device category

{
  "sources": ["510k", "pma"],
  "keywords": ["infusion pump"],
  "productCodes": ["LKK"],
  "maxResults": 25
}

Track named competitors

applicants matches the applicant field as a case-insensitive substring, so a partial company name works.

{
  "sources": ["510k", "pma"],
  "applicants": ["Medtronic", "Boston Scientific"],
  "maxResults": 100
}

PMA approvals only, from an explicit date

{
  "sources": ["pma"],
  "decidedSince": "2026-07-01",
  "maxResults": 200
}

Input parameters

Input	Type	Description
sources	array	Which pathways to monitor: 510k, pma. Default: both
keywords	array	Optional, case-insensitive. Matches against device name, generic name and applicant together
applicants	array	Optional, case-insensitive substring match on the applicant
productCodes	array	Optional. Exact match on the FDA product code
decidedSince	string	Optional YYYY-MM-DD start date that overrides the saved watermark
maxResults	integer	Maximum total records across all sources (1–1000). Default: 100

Passing a source other than 510k or pma fails the run with a clear error rather than silently returning nothing.

How monitoring works (first run and scheduling)

The first run retrieves the prior 30 days and saves a watermark only after records have been emitted successfully. To get only-new records on every subsequent run, schedule this Actor as a saved Task so runs share the same storage — the watermark lives in the task's key-value store. A fresh unsaved run starts a fresh baseline.

A failed source emits no partial results and does not advance the watermark, so a transient outage cannot silently skip a window. An empty result from openFDA is treated as "nothing in this window", not as a failure.

Honest limitations

• Filtering happens after retrieval. keywords, applicants and productCodes are applied to the records this Actor fetched, not pushed down into the openFDA query. A narrow filter over a busy window can therefore return far fewer rows than maxResults, because the cap is applied to what was fetched first. Widen decidedSince if a specific filter looks under-productive.
• maxResults is a total across sources, consumed in the order you list them. Cap at 100 with 510k first and a busy month, and pma may contribute nothing that run.
• genericName is PMA-only and is always null on 510(k) rows, because the 510(k) endpoint does not publish it.
• decisionDescription means different things per source. On 510(k) it is prose ("Substantially Equivalent"); on PMA it is the raw decision code. Read it together with source.
• expedited is true or null, never false. The FDA sets a flag when review was expedited and publishes nothing when it was not, so absence is not a documented negative.
• productCodes is exact matching, not a prefix or a substring. LKK will not match LKKA.
• Clearance is not the same as marketing. A 510(k) clearance or PMA approval means the FDA permitted the device; it does not tell you the device shipped, or when.
• Decision dates can be revised upstream. openFDA republishes its device files periodically, so a record can appear slightly after its decision date.

Reliability

Per-source diagnostics are written to the RUN_SUMMARY key-value record — never into your paid results. Failures carry structured reason codes and prevent the watermark from advancing. The Actor identifies itself to openFDA and rate-limits its requests.

Every record carries retrievedAt, a url into the FDA's own CDRH database, and the untouched source record in raw, so you can check any row against the agency yourself.

Maintained against the upstream API. If openFDA changes its schema or an endpoint moves, report it through the Issues tab and it gets fixed.

Integrations

Connect this Actor to Make, Zapier, n8n, Slack, Google Sheets, Airtable or any HTTP endpoint through Apify integrations. A weekly Task can post new clearances in your product codes into a regulatory channel, or fire a webhook so a competitive-intelligence digest is assembled the moment a decision publishes. Datasets export as JSON, CSV, Excel, XML, RSS or HTML.

API usage

curl -X POST "https://api.apify.com/v2/acts/oneshotventure~fda-clearances/runs?token=YOUR_TOKEN" \
  -H "Content-Type: application/json" \
  -d '{"sources": ["510k"], "keywords": ["infusion pump"], "maxResults": 25}'

Python, JavaScript, PHP and CLI clients are documented under Apify API clients.

Use with AI agents (MCP)

This Actor is callable from any MCP-compatible client — Claude, Cursor, VS Code or your own agent — through the Apify MCP server. The input schema is fully described and every record uses one stable, flat JSON shape, so an agent can call it and read the result without a parsing step. Because it reads the official openFDA API rather than a rendered page, the answer an agent gets is the same one the source publishes.

Factual regulatory data. Not medical, clinical or investment advice.

Frequently asked questions

Is there a free FDA 510(k) API?

Yes — openFDA publishes both the 510(k) and PMA device decision datasets as an open API with no key required. This Actor is the merging, filtering and change-feed layer over both.

What is the difference between a 510(k) and a PMA?

A 510(k) is a premarket notification: the manufacturer shows the device is substantially equivalent to one already on the market. A PMA is premarket approval, the stricter pathway for higher-risk devices, requiring clinical evidence of safety and effectiveness. This Actor covers both, tagged in source.

How do I track new device clearances for a competitor?

Put their company name in applicants — matching is a case-insensitive substring, so a partial name works — save the Actor as a Task, and schedule it.

How do I monitor a specific device category?

Use productCodes with the FDA product code, which is exact-matched. Add keywords if you would rather match on device naming than on the code.

What is a product code?

A three-letter FDA classification identifying a device type, e.g. LKK. It is the most precise way to scope this feed, and every output row carries the one it matched.

Does this include device recalls or adverse events?

No. This Actor covers clearance and approval decisions only. For recalls and enforcement, see the recalls Actor below.

Does clearance mean the device is on sale?

No. It means the FDA permitted marketing. Whether and when the manufacturer actually ships is not in this data.

Why did my filtered run return so few results?

Because filters are applied after retrieval. Widen the window with decidedSince or raise maxResults so more records are fetched before your filter narrows them.

Related actors

• US Product Recalls Monitor — CPSC and FDA food, drug and device recalls and enforcement reports.
• ClinicalTrials.gov Monitor — newly posted studies by condition and sponsor.
• NPI Registry Lookup — US healthcare provider search and verification.
• Federal Register Monitor — new FDA rules, proposed rules and notices.

Disclaimer

Unofficial independent tool. Not affiliated with or endorsed by the FDA or openFDA. Data is public government data retrieved from the official openFDA API.